REG - GSK PLC - Positive mRNA flu vaccine Phase II headline data

GSKAnnouncement

12/09/2024 07:00

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RNS Number : 8607D  GSK PLC  12 September 2024

Issued: 12 September 2024, London UK

 

GSK announces positive headline data from phase II seasonal influenza mRNA
vaccine programme

 

·   A vaccine candidate formulation demonstrated positive A and B strain
immune responses relative to standard of care in both younger and older adults

·   mRNA platform elicits strong overall antibody titres with an acceptable
safety profile

·   Data support progression to phase III clinical trials

 

 

GSK plc (LSE/NYSE: GSK) today announced positive headline results of a phase
II trial (NCT06431607) for its mRNA seasonal influenza vaccine programme. The
trial studied a range of mRNA formulations in older and younger adults to
evaluate vaccine candidates that could improve immune responses against
influenza A and B strains, compared to the current standard of care.

 

In both younger and older adults, pre-defined success criteria were met.
Interim data suggest the vaccine candidates have an acceptable safety and
reactogenicity profile for all mRNA formulations tested.

 

These results build on the previous phase II trial and confirm the mRNA
platform elicits strong overall antibody titres with an acceptable safety
profile. With these results, the GSK mRNA seasonal influenza vaccine programme
will progress into late-stage clinical development.

 

GSK's Chief Scientific Officer, Tony Wood said: "This marks a significant
advancement in our mRNA programme and these data support moving into
late-stage development. Ultimately, our goal is to develop a new best-in-class
vaccine to bring greater protection to people through the influenza season."

 

GSK recently signed a new licensing agreement with CureVac to assume full
control of developing and manufacturing influenza and COVID-19 candidate
vaccines. GSK continues to develop and optimise its mRNA capabilities through
investments and partnerships, including in AI/ML-based sequence optimisation,
nanoparticle design and manufacturing.

 

About study NCT06431607 https://www.clinicaltrials.gov/study/NCT06431607
(https://www.clinicaltrials.gov/study/NCT06431607)

The phase II study assesses the reactogenicity, safety, and immunogenicity of
different dose levels of a modified, multivalent vaccine candidate, encoding
antigens matched to all three WHO-recommended influenza strains. The study
includes 250 healthy younger adults aged 18 to 64 and 250 healthy older adults
aged 65 to 85. In each age group, different dose levels were tested in
comparison to an age-appropriate, licensed comparator vaccine.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

 

 GSK enquiries

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                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855       (Philadelphia)

 

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q2 Results for 2024.

 

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